Vaxart Initiates Next Phase of Groundbreaking COVID-19 Trial
Vaxart Receives Approval to Start Large-Scale COVID-19 Trial
Vaxart, Inc. (Nasdaq: VXRT), based in South San Francisco, recently achieved a significant milestone by receiving approval from the Biomedical Advanced Research and Development Authority (BARDA). This green light permits the company to initiate dosing for a substantial 10,000-participant segment of its Phase 2b clinical trial, which is focused on evaluating its pioneering oral pill COVID-19 vaccine candidate.
“We are thrilled to receive BARDA's approval to proceed with dosing in this extensive study. We anticipate administering the first dose to a participant in this vital cohort soon,” said Steven Lo, the Chief Executive Officer of Vaxart. “Our partnership with HHS and BARDA is invaluable, and we sincerely appreciate their continued support in advancing our clinical development program.”
Understanding the Phase 2b Clinical Trial
This Phase 2b trial is a double-blind, multi-center study that is randomized and comparator-controlled. It aims to investigate the efficacy, safety, and immunogenicity of Vaxart's oral COVID-19 vaccine candidate against an already authorized mRNA COVID-19 vaccine. This rigorous approach seeks to provide comprehensive insights into the vaccine’s performance in adults who have had prior vaccinations against COVID-19.
Funding and Support for Development
Vaxart is securing funding through Project NextGen, a remarkable initiative led by BARDA in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). This initiative boasts a formidable budget of $5 billion aimed at fast-tracking the development of innovative COVID-19 vaccines and therapeutics. Through the Rapid Response Partnership Vehicle (RRPV) Consortium, Vaxart has secured a project award valued up to $460.7 million, with funding received from federal sources.
Innovations in Vaccine Delivery
Vaxart is at the forefront of redefining vaccine delivery methods. The company’s oral recombinant vaccines are engineered to be administered in pill form, providing a novel approach to vaccination that can be stored and shipped without refrigeration, significantly reducing logistical burdens. This method not only addresses the challenge of needle-stick injuries but also opens new avenues for vaccine administration that are far more patient-friendly.
Currently, Vaxart is advancing several development programs, including pill vaccines designed to tackle threats like coronavirus, norovirus, and influenza. Additionally, they are working on a therapeutic vaccine for human papillomavirus (HPV), which marks their entry into immune-oncology. The company has also filed extensive patent applications globally to protect its innovative technologies and creations related to oral vaccination.
Continued Commitment to Innovation
The commitment to innovation at Vaxart is palpable and evident in their strategic planning and execution. They are firmly positioned within the biotechnology landscape, committed to addressing unmet medical needs through their groundbreaking approaches. The potential of their vaccine pill platform adds a promising chapter to the future of immunization worldwide.
Frequently Asked Questions
What is the purpose of the Phase 2b trial initiated by Vaxart?
The Phase 2b trial aims to evaluate the efficacy, safety, and immunogenicity of Vaxart's oral COVID-19 vaccine compared to an approved mRNA vaccine.
Who is funding Vaxart’s clinical trial?
The trial is funded through Project NextGen, an initiative led by BARDA and NIAID, with Vaxart's project award valued at up to $460.7 million.
What makes Vaxart’s vaccine delivery method unique?
Vaxart’s vaccines use an oral pill form, eliminating the need for refrigeration and reducing the risks associated with needle-stick injuries.
What other vaccines is Vaxart developing?
In addition to its COVID-19 vaccine, Vaxart is developing vaccines targeting norovirus, influenza, and a therapeutic vaccine for HPV.
How can I contact Vaxart for more information?
You can reach Vaxart's Media and Investor Relations through Matt Steinberg at IR@vaxart.com or by calling (646) 871-8481.
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